Liver FibrosisNCT06147934
Liver and Spleen Stiffness Measured by 2D-SWE for Diagnosis of Liver Fibrosis in Patients With cACLD
An observational study of Liver Fibrosis and Liver Cirrhosis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Liver Cirrhosis
- What is being tested?
- Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10kPa no previous decompensation symptoms.
Who may be able to join
- Age≥18 years old;
- Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
- No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
- Informed consent has been signed.
Who cannot join
- Hepatocellular carcinoma or other advanced malignant tumor;
- Acute liver disease or ALT≥5×ULN;
- Persistent substance abuse other than alcohol;
- Pregnancy or HIV infection;
- There are contraindications of percutaneous liver biopsy (such as serious abnormality of coagulation function, etc.);
- There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI≥30, etc.);
- Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, 519000
Xi Liu, PhD, +86 15992670630, liuxi26@mail.sysu.edu.cn
About this study
Official title: Liver and Spleen Stiffness Measured by 2D-shear Wave Elastography for Diagnosis of Liver Fibrosis in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study
A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing liver fibrosis.
Read the detailed description
Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10 kilopascal (kPa) and with no previous decompensation symptoms.
Patients will be asked to sign an informed consent form. After that, researchers will assess the eligibility of the participants according to inclusion and exclusion criteria, and record their demographic data, history of disease, and the etiology of liver disease.
The participants will be required to complete relevant laboratory tests such as blood routine, liver function, kidney function, coagulation function and etiology. After completing the tests, the results will be recorded by primary researchers.
Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be conducted by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Abdominal ultrasound findings, liver stiffness, spleen stiffness, spleen thickness, spleen diameter, portal vein trunk diameter will be recorded by primary researchers.
TE examination will be conducted by experienced nurses, instructing patients to have a fasting period of at least 4 hours prior to the tests. An interval of no more than 1 week should separate the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if the interquartile range to median ratio (IQR/med) is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Liver stiffness, spleen stiffness and controlled attenuation parameter (CAP) will be recorded by primary researchers.
Liver biopsy will be conducted by experienced interventionists and reported by pathologists. There should be a maximum interval of no more than 1 month between the liver biopsy and ultrasound examination, and the length of specimen should be more than 1.0cm. Primary researchers will record the length of specimen, histological stage, etiology of liver disease, immunohistochemistry results and so on.
Demographic characteristics and laboratory results will be collected to describe participants' condition, and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (AUROC) of 2D-SWE will be compared with that of TE in diagnosing liver fibrosis, and the cut-off value of 2D-SWE for diagnosing liver fibrosis will be explored.
- Conditions
- Liver Fibrosis, Liver Cirrhosis
- Being tested
- Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)
- Keywords
- 2D-SWE, Liver Cirrhosis, Liver Fibrosis, Liver Stiffness, Spleen Stiffness
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)Diagnostic test
Index test: TE examination will be completed by experienced nurses, requiring fasting for more than 4 hours before the examination and an interval of no more than 1 week from the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if IQR/med is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be completed by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination.
Reference standard: Liver biopsy will be conducted by experienced interventionists and reported by pathologists. There should be a maximum interval of no more than 1 month between the liver biopsy and ultrasound examination, and the length of specimen should be more than 1.0cm.
| Study group | Role | What they receive |
|---|---|---|
| study group | All participants included will be in one study group. Receives: Diagnostic Test: Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 2D-SWE
True Positive/ (True Positive+False Negative) ×100%
Measured: Through study completion, an average of 2 year
Specificity of 2D-SWE
True Negative/ (True Negative+False Positive) ×100%
Measured: Through study completion, an average of 2 year
Positive Predictive Value of 2D-SWE
True Positive/ (True Positive+False Positive) ×100%
Measured: Through study completion, an average of 2 year
Negative Predictive Value of TE and 2D-SWE
True Negative/ (True Negative+False Negative) ×100%
Measured: Through study completion, an average of 2 year
Overall diagnostic performance of TE and 2D-SWE
Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is ≥ 0.9.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xi Liu, PhD, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147934
- Sponsor's protocol ID
- ZDWY.GRBK.035
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver and Spleen Stiffness Measured by 2D-shear Wave Elastography for Diagnosis of Liver Fibrosis in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT06147934
- Acronym / sponsor ID
- ZDWY.GRBK.035
- Conditions
- Liver Fibrosis, Liver Cirrhosis
- Keywords
- 2D-SWE, Liver Cirrhosis, Liver Fibrosis, Liver Stiffness, Spleen Stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing liver fibrosis.
Detailed description
Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10 kilopascal (kPa) and with no previous decompensation symptoms.
Patients will be asked to sign an informed consent form. After that, researchers will assess the eligibility of the participants according to inclusion and exclusion criteria, and record their demographic data, history of disease, and the etiology of liver disease.
The participants will be required to complete relevant laboratory tests such as blood routine, liver function, kidney function, coagulation function and etiology. After completing the tests, the results will be recorded by primary researchers.
Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be conducted by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Abdominal ultrasound findings, liver stiffness, spleen stiffness, spleen thickness, spleen diameter, portal vein trunk diameter will be recorded by primary researchers.
TE examination will be conducted by experienced nurses, instructing patients to have a fasting period of at least 4 hours prior to the tests. An interval of no more than 1 week should separate the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if the interquartile range to median ratio (IQR/med) is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Liver stiffness, spleen stiffness and controlled attenuation parameter (CAP) will be recorded by primary researchers.
Liver biopsy will be conducted by experienced interventionists and reported by pathologists. There should be a maximum interval of no more than 1 month between the liver biopsy and ultrasound examination, and the length of specimen should be more than 1.0cm. Primary researchers will record the length of specimen, histological stage, etiology of liver disease, immunohistochemistry results and so on.
Demographic characteristics and laboratory results will be collected to describe participants' condition, and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (AUROC) of 2D-SWE will be compared with that of TE in diagnosing liver fibrosis, and the cut-off value of 2D-SWE for diagnosing liver fibrosis will be explored.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)All participants included will be in one study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10kPa no previous decompensation symptoms.
Key inclusion criteria (4 listed)
- Age≥18 years old;
- Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
- No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
- Informed consent has been signed.
Key exclusion criteria (7 listed)
- Hepatocellular carcinoma or other advanced malignant tumor;
- Acute liver disease or ALT≥5×ULN;
- Persistent substance abuse other than alcohol;
- Pregnancy or HIV infection;
- There are contraindications of percutaneous liver biopsy (such as serious abnormality of coagulation function, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)Index test: TE examination will be completed by experienced nurses, requiring fasting for more than 4 hours before the examination and an interval of no more than 1 week from the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if IQR/med is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be completed by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Reference standard: Liver biopsy will be conducted by experienced interventionists and reported by pathologists. There should be a maximum interval of no more than 1 month between the liver biopsy and ultrasound examination, and the length of specimen should be more than 1.0cm. | Diagnostic test | study group |
Primary outcome
Sensitivity of 2D-SWE
Time frame: Through study completion, an average of 2 year
True Positive/ (True Positive+False Negative) ×100%
Specificity of 2D-SWE
Time frame: Through study completion, an average of 2 year
True Negative/ (True Negative+False Positive) ×100%
Positive Predictive Value of 2D-SWE
Time frame: Through study completion, an average of 2 year
True Positive/ (True Positive+False Positive) ×100%
Negative Predictive Value of TE and 2D-SWE
Time frame: Through study completion, an average of 2 year
True Negative/ (True Negative+False Negative) ×100%
Overall diagnostic performance of TE and 2D-SWE
Time frame: Through study completion, an average of 2 year
Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is ≥ 0.9.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Liu, PhD principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Liver Cirrhosis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Liu, PhD (+86 15992670630, liuxi26@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 2D-SWE (time frame: Through study completion, an average of 2 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.